There are different way to treat Crohns' disease. We would like to look at the usage pattern for 6 different drugs across four health system.
The data was derived from PEDSNET database V4.1. Orignal datasets were created and processed in SAS.
We are interested in look at different treatment pattrens based on route of administration: IV or oral(subQ) for those exposure drugs. Patients who had at least 2 visits were included in this analysis. First, let's look at IV drugs.
| chop (N=1168) |
colorado (N=245) |
nationwide (N=394) |
nemours (N=512) |
Overall (N=2319) |
|
|---|---|---|---|---|---|
| Gender | |||||
| Female | 505 (43.2%) | 91 (37.1%) | 167 (42.4%) | 205 (40.0%) | 968 (41.7%) |
| Male | 663 (56.8%) | 154 (62.9%) | 227 (57.6%) | 307 (60.0%) | 1351 (58.3%) |
| Race | |||||
| Black | 140 (12.0%) | 16 (6.5%) | 59 (15.0%) | 76 (14.8%) | 291 (12.5%) |
| Other race | 151 (12.9%) | 49 (20.0%) | 32 (8.1%) | 65 (12.7%) | 297 (12.8%) |
| White | 877 (75.1%) | 180 (73.5%) | 303 (76.9%) | 371 (72.5%) | 1731 (74.6%) |
| Ethnicity | |||||
| Hispanic | 57 (4.9%) | 29 (11.8%) | 6 (1.5%) | 57 (11.1%) | 149 (6.4%) |
| Non-hispnaic | 1100 (94.2%) | 201 (82.0%) | 387 (98.2%) | 453 (88.5%) | 2141 (92.3%) |
| Unknown | 11 (0.9%) | 15 (6.1%) | 1 (0.3%) | 2 (0.4%) | 29 (1.3%) |
| Diagnosis age (years) | |||||
| Mean (SD) | 12.8 (3.46) | 12.9 (3.66) | 13.3 (3.46) | 13.2 (3.27) | 13.0 (3.44) |
| Median [Min, Max] | 13.3 [0.507, 18.7] | 13.5 [0.591, 18.8] | 13.5 [2.65, 19.0] | 13.6 [2.80, 18.9] | 13.4 [0.507, 19.0] |
There are only 11 exposure records with treamtment started date before diagosis were excluded.
Simalarly, we can look at another IV drug Vedolizumab.
| chop (N=131) |
colorado (N=20) |
nationwide (N=23) |
nemours (N=42) |
Overall (N=216) |
|
|---|---|---|---|---|---|
| Gender | |||||
| Female | 52 (39.7%) | 11 (55.0%) | 11 (47.8%) | 24 (57.1%) | 98 (45.4%) |
| Male | 79 (60.3%) | 9 (45.0%) | 12 (52.2%) | 18 (42.9%) | 118 (54.6%) |
| Race | |||||
| Black | 12 (9.2%) | 2 (10.0%) | 4 (17.4%) | 7 (16.7%) | 25 (11.6%) |
| Other race | 24 (18.3%) | 3 (15.0%) | 4 (17.4%) | 6 (14.3%) | 37 (17.1%) |
| White | 95 (72.5%) | 15 (75.0%) | 15 (65.2%) | 29 (69.0%) | 154 (71.3%) |
| Ethnicity | |||||
| Hispanic | 9 (6.9%) | 4 (20.0%) | 1 (4.3%) | 6 (14.3%) | 20 (9.3%) |
| Non-hispnaic | 121 (92.4%) | 16 (80.0%) | 22 (95.7%) | 36 (85.7%) | 195 (90.3%) |
| Unknown | 1 (0.8%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (0.5%) |
| Diagnosis age (years) | |||||
| Mean (SD) | 10.9 (4.78) | 11.0 (2.67) | 11.4 (4.53) | 13.7 (2.58) | 11.5 (4.35) |
| Median [Min, Max] | 11.5 [1.05, 18.2] | 11.4 [5.15, 15.3] | 12.0 [3.23, 18.9] | 14.1 [7.74, 17.2] | 11.9 [1.05, 18.9] |
Let's look at oral drug. First, Azathioprine, which is normally taken once per day, We consider more than 90 days from last exposure as new episode.
| chop (N=59) |
colorado (N=112) |
nationwide (N=22) |
nemours (N=110) |
Overall (N=303) |
|
|---|---|---|---|---|---|
| Gender | |||||
| Female | 28 (47.5%) | 71 (63.4%) | 14 (63.6%) | 62 (56.4%) | 175 (57.8%) |
| Male | 31 (52.5%) | 41 (36.6%) | 8 (36.4%) | 48 (43.6%) | 128 (42.2%) |
| Race | |||||
| Black | 7 (11.9%) | 8 (7.1%) | 4 (18.2%) | 16 (14.5%) | 35 (11.6%) |
| Other race | 8 (13.6%) | 16 (14.3%) | 1 (4.5%) | 12 (10.9%) | 37 (12.2%) |
| White | 44 (74.6%) | 88 (78.6%) | 17 (77.3%) | 82 (74.5%) | 231 (76.2%) |
| Ethnicity | |||||
| Non-hispnaic | 59 (100%) | 93 (83.0%) | 22 (100%) | 101 (91.8%) | 275 (90.8%) |
| Hispanic | 0 (0%) | 17 (15.2%) | 0 (0%) | 6 (5.5%) | 23 (7.6%) |
| Unknown | 0 (0%) | 2 (1.8%) | 0 (0%) | 3 (2.7%) | 5 (1.7%) |
| Diagnosis age (years) | |||||
| Mean (SD) | 12.4 (3.28) | 12.5 (3.75) | 12.9 (3.47) | 12.8 (3.03) | 12.7 (3.38) |
| Median [Min, Max] | 12.6 [4.68, 17.9] | 12.8 [2.86, 18.6] | 12.3 [7.88, 18.6] | 13.1 [5.75, 17.8] | 12.8 [2.86, 18.6] |
| site | episode | Patients | percent |
|---|---|---|---|
| chop | 1 | 59 | 100 |
| chop | 2 | 21 | 36 |
| chop | 3 | 7 | 12 |
| chop | 4 | 3 | 5 |
| chop | 5 | 2 | 3 |
| colorado | 1 | 112 | 100 |
| colorado | 2 | 44 | 39 |
| colorado | 3 | 21 | 19 |
| colorado | 4 | 9 | 8 |
| colorado | 5 | 2 | 2 |
| colorado | 6 | 1 | 1 |
| colorado | 7 | 1 | 1 |
| colorado | 8 | 1 | 1 |
| colorado | 9 | 1 | 1 |
| colorado | 10 | 1 | 1 |
| nationwide | 1 | 22 | 100 |
| nationwide | 2 | 5 | 23 |
| nationwide | 3 | 1 | 5 |
| nationwide | 4 | 1 | 5 |
| nationwide | 5 | 1 | 5 |
| nemours | 1 | 110 | 100 |
| nemours | 2 | 26 | 24 |
| nemours | 3 | 7 | 6 |
| nemours | 4 | 2 | 2 |
Using Crohon's diagnosis data to last visit date as study period, we standardize the treatment duration by percentage of days account for study period.
Another drugs we are going to look at is: Methotrexate. This drug has two forms: Oral or subcutaneous (subQ). We apply same rule as Azathioprine for episode definition.
| chop (N=472) |
colorado (N=155) |
nationwide (N=247) |
nemours (N=303) |
Overall (N=1177) |
|
|---|---|---|---|---|---|
| Gender | |||||
| Female | 178 (37.7%) | 31 (20.0%) | 31 (12.6%) | 81 (26.7%) | 321 (27.3%) |
| Male | 294 (62.3%) | 124 (80.0%) | 216 (87.4%) | 222 (73.3%) | 856 (72.7%) |
| Race | |||||
| Black | 41 (8.7%) | 3 (1.9%) | 23 (9.3%) | 36 (11.9%) | 103 (8.8%) |
| Other race | 67 (14.2%) | 27 (17.4%) | 14 (5.7%) | 47 (15.5%) | 155 (13.2%) |
| White | 364 (77.1%) | 125 (80.6%) | 210 (85.0%) | 220 (72.6%) | 919 (78.1%) |
| Ethnicity | |||||
| Hispanic | 23 (4.9%) | 15 (9.7%) | 3 (1.2%) | 32 (10.6%) | 73 (6.2%) |
| Non-hispnaic | 445 (94.3%) | 133 (85.8%) | 244 (98.8%) | 270 (89.1%) | 1092 (92.8%) |
| Unknown | 4 (0.8%) | 7 (4.5%) | 0 (0%) | 1 (0.3%) | 12 (1.0%) |
| Diagnosis age (years) | |||||
| Mean (SD) | 12.6 (3.54) | 12.5 (3.56) | 13.3 (3.18) | 12.9 (3.08) | 12.8 (3.36) |
| Median [Min, Max] | 13.1 [2.02, 18.6] | 12.7 [3.70, 18.3] | 13.4 [2.65, 18.5] | 13.2 [2.90, 18.7] | 13.2 [2.02, 18.7] |
| site | episode | Patients | percent |
|---|---|---|---|
| chop | 1 | 472 | 100 |
| chop | 2 | 172 | 36 |
| chop | 3 | 79 | 17 |
| chop | 4 | 36 | 8 |
| chop | 5 | 15 | 3 |
| chop | 6 | 6 | 1 |
| chop | 7 | 5 | 1 |
| chop | 8 | 2 | 0 |
| chop | 9 | 2 | 0 |
| colorado | 1 | 155 | 100 |
| colorado | 2 | 66 | 43 |
| colorado | 3 | 24 | 15 |
| colorado | 4 | 7 | 5 |
| colorado | 5 | 1 | 1 |
| nationwide | 1 | 247 | 100 |
| nationwide | 2 | 94 | 38 |
| nationwide | 3 | 38 | 15 |
| nationwide | 4 | 11 | 4 |
| nationwide | 5 | 2 | 1 |
| nationwide | 6 | 1 | 0 |
| nemours | 1 | 303 | 100 |
| nemours | 2 | 96 | 32 |
| nemours | 3 | 20 | 7 |
| nemours | 4 | 4 | 1 |
| nemours | 5 | 1 | 0 |
Using similar standarization, we can show new treatment duration by percent of study period accordingly.
Given the special usage of Humira, we can look at the gaps between doses. The recommended subcutaneous dosage of HUMIRA for adult patients with Crohn's disease (CD) is 160 mg initially on Day 1 (given in one day or split over two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a dosage of 40 mg every other week.
| chop (N=449) |
colorado (N=89) |
nationwide (N=125) |
nemours (N=412) |
Overall (N=1075) |
|
|---|---|---|---|---|---|
| Gender | |||||
| Female | 199 (44.3%) | 37 (41.6%) | 60 (48.0%) | 194 (47.1%) | 490 (45.6%) |
| Male | 250 (55.7%) | 52 (58.4%) | 65 (52.0%) | 218 (52.9%) | 585 (54.4%) |
| Race | |||||
| Black | 32 (7.1%) | 5 (5.6%) | 12 (9.6%) | 49 (11.9%) | 98 (9.1%) |
| Other race | 68 (15.1%) | 12 (13.5%) | 10 (8.0%) | 76 (18.4%) | 166 (15.4%) |
| White | 349 (77.7%) | 72 (80.9%) | 103 (82.4%) | 287 (69.7%) | 811 (75.4%) |
| Ethnicity | |||||
| Hispanic | 20 (4.5%) | 6 (6.7%) | 1 (0.8%) | 58 (14.1%) | 85 (7.9%) |
| Non-hispnaic | 427 (95.1%) | 80 (89.9%) | 124 (99.2%) | 350 (85.0%) | 981 (91.3%) |
| Unknown | 2 (0.4%) | 3 (3.4%) | 0 (0%) | 4 (1.0%) | 9 (0.8%) |
| Diagnosis age (years) | |||||
| Mean (SD) | 13.3 (3.17) | 12.6 (3.37) | 13.5 (3.13) | 13.4 (2.97) | 13.3 (3.11) |
| Median [Min, Max] | 13.6 [2.02, 18.6] | 12.8 [2.93, 18.3] | 13.6 [6.43, 18.6] | 13.7 [4.18, 18.0] | 13.6 [2.02, 18.6] |
| site | visit | mean | median |
|---|---|---|---|
| nationwide | 2 | 372.10870 | 251.5 |
| nationwide | 3 | 346.95455 | 292.5 |
| nationwide | 4 | 261.33333 | 336.0 |
| nationwide | 5 | 411.16667 | 224.5 |
| nationwide | 6 | 154.50000 | 154.5 |
| nemours | 2 | 111.34441 | 29.0 |
| nemours | 3 | 118.93411 | 73.5 |
| nemours | 4 | 123.66019 | 80.5 |
| nemours | 5 | 118.61783 | 92.0 |
| nemours | 6 | 139.27778 | 97.0 |
| colorado | 2 | 154.19355 | 35.0 |
| colorado | 3 | 155.65854 | 128.0 |
| colorado | 4 | 130.66667 | 51.0 |
| colorado | 5 | 170.21053 | 100.0 |
| colorado | 6 | 100.13333 | 62.0 |
| chop | 2 | 59.26185 | 24.0 |
| chop | 3 | 56.83024 | 28.0 |
| chop | 4 | 69.83286 | 28.0 |
| chop | 5 | 47.52888 | 28.0 |
| chop | 6 | 53.53035 | 28.0 |
To check Humira treatment timeline, we also put treatment start and end in segments.
We assume that Stelera pattern is similar both in induction and subQ.
| chop (N=129) |
colorado (N=17) |
nationwide (N=23) |
nemours (N=66) |
Overall (N=235) |
|
|---|---|---|---|---|---|
| Gender | |||||
| Female | 66 (51.2%) | 9 (52.9%) | 15 (65.2%) | 37 (56.1%) | 127 (54.0%) |
| Male | 63 (48.8%) | 8 (47.1%) | 8 (34.8%) | 29 (43.9%) | 108 (46.0%) |
| Race | |||||
| Black | 11 (8.5%) | 3 (17.6%) | 0 (0%) | 7 (10.6%) | 21 (8.9%) |
| Other race | 17 (13.2%) | 1 (5.9%) | 1 (4.3%) | 10 (15.2%) | 29 (12.3%) |
| White | 101 (78.3%) | 13 (76.5%) | 22 (95.7%) | 49 (74.2%) | 185 (78.7%) |
| Ethnicity | |||||
| Hispanic | 8 (6.2%) | 1 (5.9%) | 0 (0%) | 12 (18.2%) | 21 (8.9%) |
| Non-hispnaic | 121 (93.8%) | 16 (94.1%) | 23 (100%) | 54 (81.8%) | 214 (91.1%) |
| Diagnosis age (years) | |||||
| Mean (SD) | 13.0 (3.07) | 12.9 (2.75) | 12.4 (2.90) | 12.9 (3.01) | 12.9 (3.00) |
| Median [Min, Max] | 13.1 [4.02, 19.0] | 12.4 [6.28, 17.7] | 12.0 [6.44, 18.1] | 12.5 [6.03, 18.0] | 12.6 [4.02, 19.0] |
| site | visit | Mean | Median | Q1 | Q3 |
|---|---|---|---|---|---|
| chop | 2 | 49 | 18 | 6 | 42 |
| chop | 3 | 45 | 36 | 14 | 56 |
| chop | 4 | 51 | 40 | 18 | 56 |
| chop | 5 | 63 | 50 | 29 | 64 |
| chop | 6 | 56 | 36 | 26 | 60 |
| chop | 7 | 57 | 47 | 24 | 66 |
| chop | 8 | 48 | 30 | 22 | 53 |
| chop | 9 | 52 | 29 | 22 | 48 |
| chop | 10 | 52 | 36 | 27 | 61 |
| chop | 11 | 48 | 34 | 26 | 51 |
| chop | 12 | 49 | 29 | 25 | 54 |
| chop | 13 | 43 | 32 | 26 | 57 |
| chop | 14 | 49 | 30 | 26 | 48 |
| chop | 15 | 33 | 32 | 25 | 42 |
| chop | 16 | 32 | 30 | 26 | 40 |
| chop | 17 | 41 | 31 | 26 | 42 |
| chop | 18 | 131 | 45 | 40 | 148 |
| chop | 19 | 55 | 30 | 13 | 85 |
| chop | 20 | 55 | 28 | 22 | 42 |
| chop | 21 | 63 | 29 | 28 | 66 |
| chop | 22 | 22 | 22 | 21 | 25 |
| chop | 23 | 21 | 24 | 18 | 24 |
| chop | 24 | 30 | 30 | 25 | 36 |
| chop | 25 | 28 | 26 | 24 | 26 |
| chop | 26 | 30 | 28 | 28 | 30 |
| chop | 27 | 19 | 23 | 7 | 29 |
| chop | 28 | 32 | 29 | 28 | 32 |
| chop | 29 | 35 | 33 | 30 | 38 |
| chop | 30 | 22 | 22 | 13 | 32 |
| chop | 31 | 29 | 29 | 29 | 29 |
| chop | 32 | 45 | 45 | 45 | 45 |
| chop | 33 | 21 | 21 | 21 | 21 |
| chop | 34 | 40 | 40 | 40 | 40 |
| chop | 35 | 1 | 1 | 1 | 1 |
| chop | 36 | 26 | 26 | 26 | 26 |
| chop | 37 | 32 | 32 | 32 | 32 |
| chop | 38 | 60 | 60 | 60 | 60 |
| chop | 39 | 52 | 52 | 52 | 52 |
| chop | 40 | 54 | 54 | 54 | 54 |
| chop | 41 | 12 | 12 | 12 | 12 |
| colorado | 2 | 75 | 16 | 15 | 85 |
| colorado | 3 | 298 | 274 | 242 | 427 |
| colorado | 4 | 20 | 7 | 4 | 28 |
| colorado | 5 | 70 | 70 | 36 | 104 |
| colorado | 6 | 56 | 56 | 56 | 56 |
| colorado | 7 | 195 | 195 | 195 | 195 |
| colorado | 8 | 35 | 35 | 35 | 35 |
| nationwide | 2 | 439 | 462 | 56 | 693 |
| nemours | 2 | 78 | 21 | 6 | 55 |
| nemours | 3 | 105 | 56 | 20 | 192 |
| nemours | 4 | 131 | 103 | 24 | 208 |
| nemours | 5 | 167 | 73 | 32 | 262 |
| nemours | 6 | 151 | 120 | 30 | 182 |
| nemours | 7 | 94 | 89 | 14 | 138 |
| nemours | 8 | 168 | 130 | 80 | 208 |
| nemours | 9 | 20 | 7 | 4 | 30 |
| nemours | 10 | 118 | 118 | 94 | 143 |
| nemours | 11 | 109 | 136 | 89 | 142 |
| nemours | 12 | 84 | 67 | 55 | 104 |
| nemours | 13 | 56 | 56 | 56 | 56 |
| nemours | 14 | 112 | 112 | 112 | 112 |
| nemours | 15 | 56 | 56 | 56 | 56 |
| nemours | 16 | 63 | 63 | 63 | 63 |
| nemours | 17 | 56 | 56 | 56 | 56 |
| nemours | 18 | 56 | 56 | 56 | 56 |
| nemours | 19 | 1 | 1 | 1 | 1 |
| nemours | 20 | 230 | 230 | 230 | 230 |
| nemours | 21 | 152 | 152 | 152 | 152 |
| nemours | 22 | 252 | 252 | 252 | 252 |
Similarly, we would like to look at the timeline of Stelera treatment.